RecruitingNot ApplicableNCT07172464

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

Sponsor

Recross Cardio, Inc.

Enrollment

15 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

Cryptogenic Stroke PFO - Patent Foramen Ovale PFO PFO-associated Stroke Patent foramen ovale

Summary

The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is: • Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO. Participants will: * Undergo the procedure to implant the P3 Occluder System, if deemed appropriate. * Visit their doctor at 1 month, 3 months, 6 months, 1 year, and 5 years after the procedure for follow up exams. * Answer a phone call from study staff at 2 years, 3 years, and 4 years after the procedure to answer a survey.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Recross P3 Occluder (P3O) System for people with cryptogenic stroke, pfo, and other related conditions. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERecross P3 Occluder (P3O) System

The Recross P3 Occluder (P3O) is being developed for the purpose of transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients with PFO-associated stroke.